cobas 6000 Modular Series system — Class II medical device recall Z-0909-2018
Terminated recall by Roche Diagnostics Corporation, reported 2018-03-14, distributed nationwide. A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and the cobas¿ 8000 MODULAR Analyzer
| Recall number | Z-0909-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2017-07-18 |
| Classified | 2018-03-06 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2018-07-13 |
| Distributed | Nationwide (US) |
| Quantity | 3,433 |
| Serial numbers | 0612-05, 0614-08, 0614-14, 0617-09, 0618-16, 0618-18, 0618-19, 0619-03, 0620-20, 0621-05, 0621-11, 0621-20, 0622-08, 0623-02, 0623-04, 0623-08, 0623-11, 0623-12, 0623-16, 0623-17, 0624-15, 0624-16, 0624-18, 0625-03, 0625-09 and 475 more |
| Model numbers | 04745914001 |
Product
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
Reason for recall
A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and the cobas¿ 8000 MODULAR Analyzer Series - c502 Operator Manuals to prevent operator injury during maintenance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0909-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.